COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02415400




Registration number
NCT02415400
Ethics application status
Date submitted
9/04/2015
Date registered
14/04/2015
Date last updated
11/06/2020

Titles & IDs
Public title
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Scientific title
An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Secondary ID [1] 0 0
2014-002004-24
Secondary ID [2] 0 0
CV185-316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - vitamin K antagonist
Treatment: Drugs - Acetylsalicylic acid
Other interventions - Acetylsalicylic acid placebo

Active Comparator: Apixaban - 5 mg or 2.5 mg Apixaban tablets orally twice per day

Active Comparator: Vitamin K Antagonist - VKA tablets orally once daily

Placebo Comparator: Acetylsalicylic acid film coated tablet - 81 mg Acetylsalicylic acid film coated tablet orally once daily

Placebo Comparator: Placebo matching Acetylsalicylic acid film coated tablet - Placebo matching Acetylsalicylic acid film coated tablet once daily


Treatment: Drugs: Apixaban


Treatment: Drugs: vitamin K antagonist


Treatment: Drugs: Acetylsalicylic acid


Other interventions: Acetylsalicylic acid placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period - Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [1] 0 0
Approximately 6 months
Primary outcome [2] 0 0
The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period - Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.
N is the number of participants with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [2] 0 0
Approximately 6 months
Secondary outcome [1] 0 0
Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA - Time to first occurrence during the time the participants were treated with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [1] 0 0
Approximately 6 months
Secondary outcome [2] 0 0
The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA - Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [2] 0 0
Approximately 6 months
Secondary outcome [3] 0 0
The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin - Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.
N is the number of participants treated with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.
Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [3] 0 0
Approximately 6 months
Secondary outcome [4] 0 0
The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA - Time to first occurrence during the 6-month treatment period with Apixaban or VKA.
N is the number of participants treated with Apixaban or VKA.
n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.
Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [4] 0 0
Approximately 6 months
Secondary outcome [5] 0 0
The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin - Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.
N is the number of participants treated with aspirin or placebo.
n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.
Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Timepoint [5] 0 0
Approximately 6 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Adults with either active or a history of non-valvular atrial fibrillation or flutter
with the planned or existing use of an oral anticoagulant for prophylaxis of
thromboembolism. In addition, subjects must have had an acute coronary syndrome or
percutaneous coronary intervention with a stent within the prior 14 days

- Planned use of antiplatelet agents for at least 1 to 6 months

- Males and Females = 18 years of age

- Women of childbearing potential must have a negative serum or urine pregnancy test
within 24 hours prior to the start of study drug
Minimum age
18 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g.
prosthetic mechanical heart valve)

- Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine
clearance < 30 mL/min

- Patients with a history of intracranial hemorrhage

- Patients have had or will undergo Coronary arterial bypass graft (CABG) for their
index acute coronary syndrome (ACS) event

- Patients with known ongoing bleeding and patients with known coagulopathies

- Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists
or to aspirin

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Local Institution - Concord
Recruitment hospital [2] 0 0
Local Institution - Port Macquarie
Recruitment hospital [3] 0 0
Local Institution - Milton
Recruitment hospital [4] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
4064 - Milton
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
5024 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kansas
Country [15] 0 0
United States of America
State/province [15] 0 0
Kentucky
Country [16] 0 0
United States of America
State/province [16] 0 0
Louisiana
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Montana
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
United States of America
State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
Rhode Island
Country [31] 0 0
United States of America
State/province [31] 0 0
South Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Vermont
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Argentina
State/province [39] 0 0
BUA
Country [40] 0 0
Argentina
State/province [40] 0 0
Buenos Aires
Country [41] 0 0
Argentina
State/province [41] 0 0
Chaco
Country [42] 0 0
Argentina
State/province [42] 0 0
Cordoba
Country [43] 0 0
Argentina
State/province [43] 0 0
Santa FE
Country [44] 0 0
Argentina
State/province [44] 0 0
Corrientes
Country [45] 0 0
Argentina
State/province [45] 0 0
Santa Fe
Country [46] 0 0
Argentina
State/province [46] 0 0
Santiago Del Estero
Country [47] 0 0
Austria
State/province [47] 0 0
Graz
Country [48] 0 0
Austria
State/province [48] 0 0
Linz
Country [49] 0 0
Austria
State/province [49] 0 0
Vienna
Country [50] 0 0
Austria
State/province [50] 0 0
Wien
Country [51] 0 0
Belgium
State/province [51] 0 0
Aalst
Country [52] 0 0
Belgium
State/province [52] 0 0
Antwerpen
Country [53] 0 0
Belgium
State/province [53] 0 0
Bonheiden
Country [54] 0 0
Belgium
State/province [54] 0 0
Brasschaat
Country [55] 0 0
Belgium
State/province [55] 0 0
Bruxelles
Country [56] 0 0
Belgium
State/province [56] 0 0
Gent
Country [57] 0 0
Belgium
State/province [57] 0 0
Ieper
Country [58] 0 0
Belgium
State/province [58] 0 0
Leuven
Country [59] 0 0
Belgium
State/province [59] 0 0
Wilrijk
Country [60] 0 0
Belgium
State/province [60] 0 0
Yvoir
Country [61] 0 0
Brazil
State/province [61] 0 0
Bahia
Country [62] 0 0
Brazil
State/province [62] 0 0
Distrito Federal
Country [63] 0 0
Brazil
State/province [63] 0 0
Espirito Santo
Country [64] 0 0
Brazil
State/province [64] 0 0
Goias
Country [65] 0 0
Brazil
State/province [65] 0 0
Minas Gerais
Country [66] 0 0
Brazil
State/province [66] 0 0
Parana
Country [67] 0 0
Brazil
State/province [67] 0 0
Para
Country [68] 0 0
Brazil
State/province [68] 0 0
Pernambuco
Country [69] 0 0
Brazil
State/province [69] 0 0
RIO Grande DO SUL
Country [70] 0 0
Brazil
State/province [70] 0 0
Santa Catarina
Country [71] 0 0
Brazil
State/province [71] 0 0
SAO Paulo
Country [72] 0 0
Brazil
State/province [72] 0 0
Rio de Janeiro
Country [73] 0 0
Brazil
State/province [73] 0 0
Sao Paulo
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Burgas
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Dimitrovgrad
Country [76] 0 0
Bulgaria
State/province [76] 0 0
Haskovo
Country [77] 0 0
Bulgaria
State/province [77] 0 0
Montana
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Pazardzhik
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Pleven
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Plovdiv
Country [81] 0 0
Bulgaria
State/province [81] 0 0
Sandanski
Country [82] 0 0
Bulgaria
State/province [82] 0 0
Smolyan
Country [83] 0 0
Bulgaria
State/province [83] 0 0
Sofia
Country [84] 0 0
Bulgaria
State/province [84] 0 0
Veliko Tarnova
Country [85] 0 0
Bulgaria
State/province [85] 0 0
Vidin
Country [86] 0 0
Canada
State/province [86] 0 0
Alberta
Country [87] 0 0
Canada
State/province [87] 0 0
British Columbia
Country [88] 0 0
Canada
State/province [88] 0 0
Manitoba
Country [89] 0 0
Canada
State/province [89] 0 0
Nova Scotia
Country [90] 0 0
Canada
State/province [90] 0 0
Ontario
Country [91] 0 0
Canada
State/province [91] 0 0
Quebec
Country [92] 0 0
Canada
State/province [92] 0 0
Saskatchewan
Country [93] 0 0
Canada
State/province [93] 0 0
Montreal
Country [94] 0 0
Chile
State/province [94] 0 0
Metropolitana
Country [95] 0 0
Colombia
State/province [95] 0 0
Barranquilla
Country [96] 0 0
Colombia
State/province [96] 0 0
Bogota
Country [97] 0 0
Colombia
State/province [97] 0 0
Cali
Country [98] 0 0
Colombia
State/province [98] 0 0
Espinal
Country [99] 0 0
Colombia
State/province [99] 0 0
Medellin
Country [100] 0 0
Croatia
State/province [100] 0 0
Cakovec
Country [101] 0 0
Croatia
State/province [101] 0 0
Dubrovnik
Country [102] 0 0
Croatia
State/province [102] 0 0
Karlovac
Country [103] 0 0
Croatia
State/province [103] 0 0
Krapinske toplice
Country [104] 0 0
Croatia
State/province [104] 0 0
Opatija
Country [105] 0 0
Croatia
State/province [105] 0 0
Osijek
Country [106] 0 0
Croatia
State/province [106] 0 0
Rijeka
Country [107] 0 0
Croatia
State/province [107] 0 0
Sibenik
Country [108] 0 0
Croatia
State/province [108] 0 0
Slavonski Brod
Country [109] 0 0
Croatia
State/province [109] 0 0
Virovitica
Country [110] 0 0
Croatia
State/province [110] 0 0
Zabok
Country [111] 0 0
Croatia
State/province [111] 0 0
Zadar
Country [112] 0 0
Croatia
State/province [112] 0 0
Zagreb
Country [113] 0 0
Czechia
State/province [113] 0 0
Prague 8
Country [114] 0 0
Czechia
State/province [114] 0 0
Praha 2
Country [115] 0 0
Czechia
State/province [115] 0 0
Praha 5
Country [116] 0 0
Czechia
State/province [116] 0 0
Tabor
Country [117] 0 0
Czechia
State/province [117] 0 0
Usti Nad Orlici
Country [118] 0 0
Czechia
State/province [118] 0 0
Zlin
Country [119] 0 0
Denmark
State/province [119] 0 0
Aabenraa
Country [120] 0 0
Denmark
State/province [120] 0 0
Aarhus
Country [121] 0 0
Denmark
State/province [121] 0 0
Copenhagen
Country [122] 0 0
Denmark
State/province [122] 0 0
Frederiksburg
Country [123] 0 0
Denmark
State/province [123] 0 0
Hellerup
Country [124] 0 0
Denmark
State/province [124] 0 0
Hillerod
Country [125] 0 0
Denmark
State/province [125] 0 0
Holb?k
Country [126] 0 0
Denmark
State/province [126] 0 0
Hvidovre
Country [127] 0 0
Denmark
State/province [127] 0 0
Randers
Country [128] 0 0
Denmark
State/province [128] 0 0
Roskilde
Country [129] 0 0
Denmark
State/province [129] 0 0
Slagelse
Country [130] 0 0
France
State/province [130] 0 0
Besancon
Country [131] 0 0
France
State/province [131] 0 0
Caen
Country [132] 0 0
France
State/province [132] 0 0
Chambray-les-Tours
Country [133] 0 0
France
State/province [133] 0 0
Le Coudray
Country [134] 0 0
France
State/province [134] 0 0
Lyon
Country [135] 0 0
France
State/province [135] 0 0
Marseille
Country [136] 0 0
France
State/province [136] 0 0
Nimes
Country [137] 0 0
France
State/province [137] 0 0
Pau
Country [138] 0 0
France
State/province [138] 0 0
Pessac
Country [139] 0 0
France
State/province [139] 0 0
Toulouse
Country [140] 0 0
Germany
State/province [140] 0 0
Bad Friedrichshall
Country [141] 0 0
Germany
State/province [141] 0 0
Bad Homburg
Country [142] 0 0
Germany
State/province [142] 0 0
Berlin
Country [143] 0 0
Germany
State/province [143] 0 0
Bielefeld
Country [144] 0 0
Germany
State/province [144] 0 0
Brandenburg
Country [145] 0 0
Germany
State/province [145] 0 0
Bremen
Country [146] 0 0
Germany
State/province [146] 0 0
Chemnitz
Country [147] 0 0
Germany
State/province [147] 0 0
Dortmund
Country [148] 0 0
Germany
State/province [148] 0 0
Dresden
Country [149] 0 0
Germany
State/province [149] 0 0
Erfurt
Country [150] 0 0
Germany
State/province [150] 0 0
Erlangen
Country [151] 0 0
Germany
State/province [151] 0 0
Essen
Country [152] 0 0
Germany
State/province [152] 0 0
Frankfurt am Main
Country [153] 0 0
Germany
State/province [153] 0 0
Freiburg
Country [154] 0 0
Germany
State/province [154] 0 0
Gottingen
Country [155] 0 0
Germany
State/province [155] 0 0
Greifswald
Country [156] 0 0
Germany
State/province [156] 0 0
Hamburg
Country [157] 0 0
Germany
State/province [157] 0 0
Hansestadt Stendal
Country [158] 0 0
Germany
State/province [158] 0 0
Hennigsdorf
Country [159] 0 0
Germany
State/province [159] 0 0
Hoyerswerda
Country [160] 0 0
Germany
State/province [160] 0 0
Jena
Country [161] 0 0
Germany
State/province [161] 0 0
Karlsbad
Country [162] 0 0
Germany
State/province [162] 0 0
Kassel
Country [163] 0 0
Germany
State/province [163] 0 0
Koln
Country [164] 0 0
Germany
State/province [164] 0 0
Lahr
Country [165] 0 0
Germany
State/province [165] 0 0
Leipzig
Country [166] 0 0
Germany
State/province [166] 0 0
Limburg
Country [167] 0 0
Germany
State/province [167] 0 0
Ludenscheid
Country [168] 0 0
Germany
State/province [168] 0 0
Luebeck
Country [169] 0 0
Germany
State/province [169] 0 0
Magdeburg
Country [170] 0 0
Germany
State/province [170] 0 0
Mainz
Country [171] 0 0
Germany
State/province [171] 0 0
Mannheim
Country [172] 0 0
Germany
State/province [172] 0 0
Neuss
Country [173] 0 0
Germany
State/province [173] 0 0
Papenburg
Country [174] 0 0
Germany
State/province [174] 0 0
Regensburg
Country [175] 0 0
Germany
State/province [175] 0 0
Rostock
Country [176] 0 0
Germany
State/province [176] 0 0
Straubing
Country [177] 0 0
Germany
State/province [177] 0 0
Tubingen
Country [178] 0 0
Germany
State/province [178] 0 0
Ulm
Country [179] 0 0
Germany
State/province [179] 0 0
Villingen-Schwenningen
Country [180] 0 0
Germany
State/province [180] 0 0
Weiden i.d.OPf.
Country [181] 0 0
Germany
State/province [181] 0 0
Worms
Country [182] 0 0
Germany
State/province [182] 0 0
Wurzburg
Country [183] 0 0
Hungary
State/province [183] 0 0
Bacs-kiskun
Country [184] 0 0
Hungary
State/province [184] 0 0
Bekescsaba
Country [185] 0 0
Hungary
State/province [185] 0 0
Budapest
Country [186] 0 0
Hungary
State/province [186] 0 0
Keszthely
Country [187] 0 0
Hungary
State/province [187] 0 0
Mosonmagyarovar
Country [188] 0 0
Hungary
State/province [188] 0 0
Pecs
Country [189] 0 0
Hungary
State/province [189] 0 0
Szeged
Country [190] 0 0
Hungary
State/province [190] 0 0
Szekszard
Country [191] 0 0
Hungary
State/province [191] 0 0
Szolnok
Country [192] 0 0
India
State/province [192] 0 0
Gujarat
Country [193] 0 0
India
State/province [193] 0 0
Karnataka
Country [194] 0 0
India
State/province [194] 0 0
Amritsar
Country [195] 0 0
India
State/province [195] 0 0
Jaipur,
Country [196] 0 0
India
State/province [196] 0 0
Lucknow
Country [197] 0 0
India
State/province [197] 0 0
Madurai
Country [198] 0 0
India
State/province [198] 0 0
Mangalore
Country [199] 0 0
India
State/province [199] 0 0
New Delhi
Country [200] 0 0
India
State/province [200] 0 0
Noida
Country [201] 0 0
India
State/province [201] 0 0
Shivamogga
Country [202] 0 0
India
State/province [202] 0 0
Vadodara
Country [203] 0 0
India
State/province [203] 0 0
Vijayawada
Country [204] 0 0
Israel
State/province [204] 0 0
Afula
Country [205] 0 0
Israel
State/province [205] 0 0
Ashkelon
Country [206] 0 0
Israel
State/province [206] 0 0
Hadera
Country [207] 0 0
Israel
State/province [207] 0 0
Haifa
Country [208] 0 0
Israel
State/province [208] 0 0
Herzliya
Country [209] 0 0
Israel
State/province [209] 0 0
Holon
Country [210] 0 0
Israel
State/province [210] 0 0
Jerusalem
Country [211] 0 0
Israel
State/province [211] 0 0
Ramat-Gan
Country [212] 0 0
Israel
State/province [212] 0 0
Rehovot
Country [213] 0 0
Israel
State/province [213] 0 0
Safed
Country [214] 0 0
Israel
State/province [214] 0 0
Tel Aviv
Country [215] 0 0
Israel
State/province [215] 0 0
Tiberias
Country [216] 0 0
Italy
State/province [216] 0 0
Grosseto
Country [217] 0 0
Korea, Republic of
State/province [217] 0 0
Busan
Country [218] 0 0
Korea, Republic of
State/province [218] 0 0
Changwon
Country [219] 0 0
Korea, Republic of
State/province [219] 0 0
Daegu
Country [220] 0 0
Korea, Republic of
State/province [220] 0 0
Daejeon
Country [221] 0 0
Korea, Republic of
State/province [221] 0 0
Gwang Ju
Country [222] 0 0
Korea, Republic of
State/province [222] 0 0
Incheon
Country [223] 0 0
Korea, Republic of
State/province [223] 0 0
Seongnam-si
Country [224] 0 0
Korea, Republic of
State/province [224] 0 0
Seoul
Country [225] 0 0
Mexico
State/province [225] 0 0
Coahuila
Country [226] 0 0
Mexico
State/province [226] 0 0
Guanajuato
Country [227] 0 0
Mexico
State/province [227] 0 0
Jalisco
Country [228] 0 0
Mexico
State/province [228] 0 0
Nuevo LEON
Country [229] 0 0
Mexico
State/province [229] 0 0
Queretaro
Country [230] 0 0
Mexico
State/province [230] 0 0
QUE
Country [231] 0 0
Mexico
State/province [231] 0 0
Sinaloa
Country [232] 0 0
Mexico
State/province [232] 0 0
Aguascalientes
Country [233] 0 0
Mexico
State/province [233] 0 0
Durango
Country [234] 0 0
Mexico
State/province [234] 0 0
Puebla
Country [235] 0 0
Mexico
State/province [235] 0 0
San Luis Potosi
Country [236] 0 0
Mexico
State/province [236] 0 0
Tlalnepantla De Baz
Country [237] 0 0
Mexico
State/province [237] 0 0
Veracruz
Country [238] 0 0
Netherlands
State/province [238] 0 0
Amsterdam
Country [239] 0 0
Netherlands
State/province [239] 0 0
Arnhem
Country [240] 0 0
Netherlands
State/province [240] 0 0
Breda
Country [241] 0 0
Netherlands
State/province [241] 0 0
Ede
Country [242] 0 0
Netherlands
State/province [242] 0 0
Groningen
Country [243] 0 0
Netherlands
State/province [243] 0 0
Hardenberg
Country [244] 0 0
Netherlands
State/province [244] 0 0
Maastricht
Country [245] 0 0
Netherlands
State/province [245] 0 0
Nieuwegein
Country [246] 0 0
Netherlands
State/province [246] 0 0
Rotterdam
Country [247] 0 0
Netherlands
State/province [247] 0 0
Tilburg
Country [248] 0 0
Netherlands
State/province [248] 0 0
Uden
Country [249] 0 0
Norway
State/province [249] 0 0
Bod?
Country [250] 0 0
Norway
State/province [250] 0 0
Oslo
Country [251] 0 0
Norway
State/province [251] 0 0
Skien
Country [252] 0 0
Norway
State/province [252] 0 0
Stavanger
Country [253] 0 0
Norway
State/province [253] 0 0
Tromso
Country [254] 0 0
Peru
State/province [254] 0 0
Lima
Country [255] 0 0
Peru
State/province [255] 0 0
Callao
Country [256] 0 0
Peru
State/province [256] 0 0
Cusco
Country [257] 0 0
Poland
State/province [257] 0 0
Wielkopolskie
Country [258] 0 0
Poland
State/province [258] 0 0
Bialystok
Country [259] 0 0
Poland
State/province [259] 0 0
Bydgoszcz
Country [260] 0 0
Poland
State/province [260] 0 0
Bytom
Country [261] 0 0
Poland
State/province [261] 0 0
Chojnice
Country [262] 0 0
Poland
State/province [262] 0 0
Gdynia
Country [263] 0 0
Poland
State/province [263] 0 0
Katowice
Country [264] 0 0
Poland
State/province [264] 0 0
Kielce
Country [265] 0 0
Poland
State/province [265] 0 0
Krakow
Country [266] 0 0
Poland
State/province [266] 0 0
Lodz
Country [267] 0 0
Poland
State/province [267] 0 0
Lubin
Country [268] 0 0
Poland
State/province [268] 0 0
Opole
Country [269] 0 0
Poland
State/province [269] 0 0
Plock
Country [270] 0 0
Poland
State/province [270] 0 0
Siemianowice Slaskie
Country [271] 0 0
Poland
State/province [271] 0 0
Torun
Country [272] 0 0
Poland
State/province [272] 0 0
Warszawa
Country [273] 0 0
Poland
State/province [273] 0 0
Wloclawek
Country [274] 0 0
Poland
State/province [274] 0 0
Wroclaw
Country [275] 0 0
Portugal
State/province [275] 0 0
Almada
Country [276] 0 0
Portugal
State/province [276] 0 0
Aveiro
Country [277] 0 0
Portugal
State/province [277] 0 0
Braga
Country [278] 0 0
Portugal
State/province [278] 0 0
Coimbra
Country [279] 0 0
Portugal
State/province [279] 0 0
Covilha
Country [280] 0 0
Portugal
State/province [280] 0 0
Guimar?es
Country [281] 0 0
Portugal
State/province [281] 0 0
Leiria
Country [282] 0 0
Portugal
State/province [282] 0 0
Lisbon
Country [283] 0 0
Portugal
State/province [283] 0 0
Senhora De Hora, Matosinhos
Country [284] 0 0
Portugal
State/province [284] 0 0
Vila Real
Country [285] 0 0
Puerto Rico
State/province [285] 0 0
Caguas
Country [286] 0 0
Romania
State/province [286] 0 0
Baia Mare
Country [287] 0 0
Romania
State/province [287] 0 0
Brasov
Country [288] 0 0
Romania
State/province [288] 0 0
Bucharest
Country [289] 0 0
Romania
State/province [289] 0 0
Cluj-Napoca
Country [290] 0 0
Romania
State/province [290] 0 0
Craiova
Country [291] 0 0
Romania
State/province [291] 0 0
Oradea
Country [292] 0 0
Romania
State/province [292] 0 0
Pitesti
Country [293] 0 0
Romania
State/province [293] 0 0
Sibiu
Country [294] 0 0
Romania
State/province [294] 0 0
Targoviste
Country [295] 0 0
Romania
State/province [295] 0 0
Targu Mures
Country [296] 0 0
Romania
State/province [296] 0 0
Timisoara
Country [297] 0 0
Romania
State/province [297] 0 0
Tirgu Mures
Country [298] 0 0
Russian Federation
State/province [298] 0 0
Ekaterinburg
Country [299] 0 0
Russian Federation
State/province [299] 0 0
Gatchina
Country [300] 0 0
Russian Federation
State/province [300] 0 0
Kazan
Country [301] 0 0
Russian Federation
State/province [301] 0 0
Krasnodar
Country [302] 0 0
Russian Federation
State/province [302] 0 0
Moscow
Country [303] 0 0
Russian Federation
State/province [303] 0 0
Novosibirsk
Country [304] 0 0
Russian Federation
State/province [304] 0 0
Saint Petersburg
Country [305] 0 0
Russian Federation
State/province [305] 0 0
Samara
Country [306] 0 0
Russian Federation
State/province [306] 0 0
Saratov
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Sochi
Country [308] 0 0
Russian Federation
State/province [308] 0 0
St. Petersburg
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Tyumen
Country [310] 0 0
Serbia
State/province [310] 0 0
Belgarde
Country [311] 0 0
Serbia
State/province [311] 0 0
Belgrade
Country [312] 0 0
Serbia
State/province [312] 0 0
Nis
Country [313] 0 0
Serbia
State/province [313] 0 0
Sremska Kamenica
Country [314] 0 0
Serbia
State/province [314] 0 0
Uzice
Country [315] 0 0
Slovakia
State/province [315] 0 0
Banska Bystrica
Country [316] 0 0
Slovakia
State/province [316] 0 0
Bardejov
Country [317] 0 0
Slovakia
State/province [317] 0 0
Bratislava
Country [318] 0 0
Slovakia
State/province [318] 0 0
Brezno
Country [319] 0 0
Slovakia
State/province [319] 0 0
Kosice
Country [320] 0 0
Slovakia
State/province [320] 0 0
Nitra
Country [321] 0 0
Slovakia
State/province [321] 0 0
Spisska Nova Ves
Country [322] 0 0
Slovakia
State/province [322] 0 0
Trebisov
Country [323] 0 0
Slovakia
State/province [323] 0 0
Trencin
Country [324] 0 0
Spain
State/province [324] 0 0
Madrid
Country [325] 0 0
Spain
State/province [325] 0 0
Alicante
Country [326] 0 0
Spain
State/province [326] 0 0
Barcelona
Country [327] 0 0
Spain
State/province [327] 0 0
Cordoba
Country [328] 0 0
Spain
State/province [328] 0 0
Huelva
Country [329] 0 0
Spain
State/province [329] 0 0
Malaga
Country [330] 0 0
Spain
State/province [330] 0 0
Marbella
Country [331] 0 0
Spain
State/province [331] 0 0
Palma de Mallorca
Country [332] 0 0
Spain
State/province [332] 0 0
San Sebastian
Country [333] 0 0
Spain
State/province [333] 0 0
Valencia
Country [334] 0 0
Sweden
State/province [334] 0 0
Eskilstuna
Country [335] 0 0
Sweden
State/province [335] 0 0
Goteborg
Country [336] 0 0
Sweden
State/province [336] 0 0
Jonkoping
Country [337] 0 0
Sweden
State/province [337] 0 0
Ostersund
Country [338] 0 0
Sweden
State/province [338] 0 0
Skelleftea
Country [339] 0 0
Sweden
State/province [339] 0 0
Stockholm
Country [340] 0 0
Sweden
State/province [340] 0 0
Uppsala
Country [341] 0 0
Switzerland
State/province [341] 0 0
Bern
Country [342] 0 0
Switzerland
State/province [342] 0 0
Geneva
Country [343] 0 0
Switzerland
State/province [343] 0 0
Winterthur
Country [344] 0 0
Ukraine
State/province [344] 0 0
Cherkasy
Country [345] 0 0
Ukraine
State/province [345] 0 0
Chernivtsi
Country [346] 0 0
Ukraine
State/province [346] 0 0
Dnipropetrovsk
Country [347] 0 0
Ukraine
State/province [347] 0 0
Ivano-Frankivsk
Country [348] 0 0
Ukraine
State/province [348] 0 0
Kharkiv
Country [349] 0 0
Ukraine
State/province [349] 0 0
Kyiv
Country [350] 0 0
Ukraine
State/province [350] 0 0
Lutsk
Country [351] 0 0
Ukraine
State/province [351] 0 0
Mykolaiv
Country [352] 0 0
Ukraine
State/province [352] 0 0
Odesa
Country [353] 0 0
Ukraine
State/province [353] 0 0
Uzhhorod
Country [354] 0 0
Ukraine
State/province [354] 0 0
Vinnytsia
Country [355] 0 0
Ukraine
State/province [355] 0 0
Zhaporizhzhya
Country [356] 0 0
United Kingdom
State/province [356] 0 0
Dorset
Country [357] 0 0
United Kingdom
State/province [357] 0 0
Fife
Country [358] 0 0
United Kingdom
State/province [358] 0 0
Hertfordshire
Country [359] 0 0
United Kingdom
State/province [359] 0 0
Merseyside
Country [360] 0 0
United Kingdom
State/province [360] 0 0
Northamptonshire
Country [361] 0 0
United Kingdom
State/province [361] 0 0
South Yorkshire
Country [362] 0 0
United Kingdom
State/province [362] 0 0
Birmingham
Country [363] 0 0
United Kingdom
State/province [363] 0 0
Dudley, West Midlands
Country [364] 0 0
United Kingdom
State/province [364] 0 0
Dundee
Country [365] 0 0
United Kingdom
State/province [365] 0 0
Wolverhampton
Country [366] 0 0
Virgin Islands (U.S.)
State/province [366] 0 0
Christiansted

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist
given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial
fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in
the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors
(such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a
comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K
antagonist, such as warfarin, with or without aspirin.
Trial website
https://clinicaltrials.gov/show/NCT02415400
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications